Riik: Lõuna-Aafrika Vabariik
keel: inglise
Allikas: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
TABLET
EACH TABLET CONTAINS IBUPROFEN 400,0 mg PARACETAMOL 325,0 mg
Registered
ADCOCK INGRAM LIMITED NOCOMYPRO, film-coated tablets _Contains 400 mg ibuprofen and 325 mg paracetamol per tablet_ Page 1 of 11 1.3.2 PATIENT INFORMATION LEAFLET FOR NOCOMYPRO SCHEDULING STATUS S3 NOCOMYPRO 400 MG/325 MG FILM-COATED TABLETS IBUPROFEN/PARACETAMOL SUGAR FREE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. NOCOMYPRO is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use NOCOMYPRO carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share NOCOMYPRO with any other person. • Ask your health care provider or pharmacist if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve. WHAT IS IN THIS LEAFLET 1. What NOCOMYPRO is and what it is used for 2. What you need to know before you take NOCOMYPRO 3. How to take NOCOMYPRO 4. Possible side effects 5. How to store NOCOMYPRO 6. Contents of the pack and other information ADCOCK INGRAM LIMITED NOCOMYPRO, film-coated tablets _Contains 400 mg ibuprofen and 325 mg paracetamol per tablet_ Page 2 of 11 1. WHAT NOCOMYPRO IS AND WHAT IT IS USED FOR NOCOMYPRO contains two active ingredients. These are ibuprofen and paracetamol. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain, reducing swelling, and lowering high temperatures. Paracetamol is an analgesic which works in a different way from ibuprofen to relieve pain and fever. NOCOMYPRO is used to relieve mild and moderate pain and reduce swelling, with or without fever. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOCOMYPRO DO NOT TAKE NOCOMYPRO • if you are hypersensitive (allergic) to ibuprofen or paracetamol or any of the other ingredients of NOCOMYPRO. • If you are pregnant, do not use NSAIDs at 20 weeks or later in your pregnancy unless specifically advised to do so by your health care professional because these medicines may cause p Lugege kogu dokumenti
ADCOCK INGRAM LIMITED NOCOMYPRO, film-coated tablets _Contains 400 mg ibuprofen and 325 mg paracetamol per tablet _ Page 1 of 15 1.3.1.1 PROFESSIONAL INFORMATION FOR NOCOMYPRO SCHEDULING STATUS S3 1. NAME OF THE MEDICINE NOCOMYPRO 400 mg/325 mg, film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: Ibuprofen 400 mg Paracetamol 325 mg Sugar free For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Orange coloured, oval, film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NOCOMYPRO is indicated for the relief of mild to moderate pain of inflammatory origin or non- inflammatory origin with or without fever. ADCOCK INGRAM LIMITED NOCOMYPRO, film-coated tablets _Contains 400 mg ibuprofen and 325 mg paracetamol per tablet_ _ _ Page 2 of 15 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY DO NOT EXCEED THE RECOMMENDED DOSE. Use the lowest effective dose for the shortest possible duration of treatment. Not recommended for children under twelve years. Adults and children over 12 years: 2 tablets every 4 hours when necessary. Do not exceed 6 tablets in 24 hours. Tablets are to be taken with food or after meals with sufficient water. If taking NOCOMYPRO of pain and the pain persists for longer than 7 days, or if taking NOCOMYPRO for fever and the fever persists for longer than 3 days or if the condition deteriorates or new symptoms develop, a re-evaluation of the condition is required by the doctor. PAEDIATRIC POPULATION The safety and efficacy of NOCOMYPRO in children under 12 years of age have not yet been established. METHOD OF ADMINISTRATION For oral administration. 4.3 CONTRAINDICATIONS • Hypersensitivity to ibuprofen, paracetamol or to any of the excipients listed in section 6.1. • Avoid use of NSAIDs in women around 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/foetal renal dysfunction and premature closure of the foetal ductus arteriosus. • NOCOMYPRO is contraindicated in hea Lugege kogu dokumenti